recurrent/metastatic head and neck squamous cell carcinoma
Conditions
Interventions
Single arm treatment group:Eligible participants with PD-L1-positive expression (CPS=1) will receive Ivarmacitinib and Camrelizumab for up to 1 year.
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old; 2. ECOG physical status score of 0 or 1 point; 3. Expected survival time of more than 3 months; 4. Patients with recurrent/metastatic head and neck squamous cell carcinoma (including oral cavity, oropharynx, hypopharynx, larynx) that are incurable by histologically or cytologically confirmed local therapy, and have not received systemic anti-tumor therapy for recurrent/metastatic HNSCC; 5. Known positive PD-L1 expression (CPS>=1); 6. Oropharyngeal cancer with known HPV p16 status; 7. At least one measurable lesion according to RECIST 1.1 criteria; 8. Vital organs function normally; 9. Women of childbearing age (15~49 years old) must have a pregnancy study and the result is negative within 7 days before starting treatment; Male and female study participants of childbearing potential must agree to use effective contraception to ensure that they do not become pregnant during the study and for 3 months after stopping treatment; 10. Obtain informed consent voluntarily signed by the study participant himself, and the subject has good compliance and is willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. The primary site is nasopharynx, nasal cavity, sinuses, salivary glands, thyroid or parathyroid glands, skin or squamous cell carcinoma with unknown primary location; 2. Lesions suitable for radical local therapy; 3. Subjects with other malignancies within 5 years prior to enrollment (with subjects with other tumors that have been cured by local therapy, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ); 4. Participants with ulcers on the skin surface during the screening period, superficial or protruding skin lesions with excessive surface tension and a greater risk of rupture, or the possibility of other greater rupture risks assessed by the investigator; 5. Active central nervous system metastases and/or carcinomatous meningitis (except for the following conditions: patients with treated and stable brain metastases need to meet the following conditions: stable disease (no new/worsening neurological symptoms, seizures or intracranial hypertension), no progression on MRI within 4 weeks prior to treatment, and no corticosteroids within 14 days before the first dose; 6. Received small molecule targeted therapy (within 2 weeks or 5 half-lives, whichever is longer) before the first dose; Systemic chemotherapy (within 3 weeks); Biologics/macromolecule targeted therapy/immunotherapy (within 4 weeks); Major surgery (minor surgery requires complete recovery and an interval of more than 2 weeks); radiotherapy (within 2 weeks); 7. Organ dysfunction (such as hypertension, diabetes, etc.); 8. Uncontrolled or poorly controlled systemic disease; 9. Previous or combined history of interstitial pneumonia, severe chronic obstructive pulmonary disease combined with respiratory failure, severe pulmonary insufficiency, symptomatic bronchospasm, etc.; 10. Active bacterial, viral, fungal, rickettsia, or parasitic infection requiring systemic anti-infective therapy (unless treatment is obtained prior to study drug administration and resolves); 11. Concurrent serious, uncontrolled infection or known human immunodeficiency virus (HIV) (HIV antibody positive) infection, or diagnosis of acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or previous allogeneic tissue/organ transplantation, stem cell or bone marrow transplantation, or prior solid organ transplantation; 12. Known presence of active tuberculosis (TB); 13. Known active hepatitis B or hepatitis C or other severe liver disease; 14. Known active syphilis infection; 15. Received a live virus vaccine within 30 days prior to the first dose of study drug; 16. Residual toxic reactions (except alopecia, fatigue, and grade 2 hypothyroidism) or clinically significant laboratory abnormalities higher than grade 1 due to previous anti-tumor therapy; 17. Received immunotherapy before the first dose for any reason; 18. Known allergic reaction to any component or excipient of emaxitinib, or known allergic reaction to other previous anti-PD-1 monoclonal antibodies (including investigational drugs) or to other monoclonal antibodies of grade >=3; 19. Uncontrolled pleural, abdominal, pelvic effusion or pericardial effusion; 20. Study participants who have a positive pregnancy test or are breastfeeding. Female and male study participants who are not expected to plan to use adequate contraception during the treatment period and for 180 days after the last dose of treatment; 21. Psychiatric illness/condition that affects th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival, OS; | — |
Countries
China
Contacts
Public ContactLei Liu
West China Hospital of Sichuan University
Outcome results
None listed